A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome

Part of paid clinical trials in Fullerton, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT05946941
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Sjögren's Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Deucravacitinib — DRUG
    Specified dose on specified days
  • Placebo — OTHER
    Specified dose on specified days

Study Details

The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.

Key Dates

Start date
Sep 11, 2023
Status verified
Mar 2026
Primary completion
Nov 18, 2026
Completion
Nov 16, 2028

Study Design

Enrollment
774 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Deucravacitinib, Dose 1
  • Experimental: Deucravacitinib, Dose 2
  • Placebo Comparator: Placebo, followed by Deucravacitinib Dose 1 or Dose 2

Primary Outcome Measure

Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52 [ Time Frame: Baseline, Week 52 ]

Locations (28)

FacilityCityStateZIPSite coordinators
Local Institution - 0228FullertonCalifornia92835-
Local Institution - 0222La PalmaCalifornia90623-
Local Institution - 0218San FranciscoCalifornia94143-
Local Institution - 0203Santa MonicaCalifornia90404-
Local Institution - 0067DenverColorado80230-
Local Institution - 0049ClearwaterFlorida33765-
Local Institution - 0226Cooper CityFlorida33024-
Local Institution - 0223SarasotaFlorida34239-
Local Institution - 0140AugustaGeorgia30912-
Local Institution - 0229LawrencevilleGeorgia30046-
Local Institution - 0174SkokieIllinois60076-
Local Institution - 0016Kansas CityKansas66160-
Local Institution - 0017Baton RougeLouisiana70836-
Local Institution - 0125MonroeLouisiana71203-
Local Institution - 0187BaltimoreMaryland21224-2746-
Local Institution - 0173BostonMassachusetts02111-
Local Institution - 0131EaganMinnesota55123-
Local Institution - 0138SummitNew Jersey07901-
Local Institution - 0009AlbuquerqueNew Mexico87106-
Local Institution - 0184MineolaNew York11501-
Local Institution - 0224SalisburyNorth Carolina28144-
Local Institution - 0130DuncansvillePennsylvania16635-
Local Institution - 0022JacksonTennessee38305-
Local Institution - 0144AllenTexas75013-
Local Institution - 0227KatyTexas77494-
Local Institution - 0175PlanoTexas75024-
Local Institution - 0133SeattleWashington98195-
Local Institution - 0189SpokaneWashington99204-

Find similar trials in Fullerton, CA

By research site
Local Institution - 0228· Fullerton, CALocal Institution - 0222· La Palma, CALocal Institution - 0218· San Francisco, CALocal Institution - 0203· Santa Monica, CALocal Institution - 0067· Denver, COLocal Institution - 0049· Clearwater, FL

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